Dual-Layer Ultra-High Pressure Balloon Catheter

Product Overview

Engineered exclusively for heavily calcified vascular angioplasty, this catheter differs from standard single-layer PTCA balloons. Its dual-layer balloon film is co-extruded from composite polymers to boost rated burst pressure up to 36atm, delivering powerful dilation for sclerotic, calcified arterial plaques in severe coronary and lower-limb occlusions. Refined multi-fold shaping with thermal treatment creates an ultra-compact folded profile that navigates highly stenotic calcified channels smoothly. Bidirectional laser-welded tip eliminates sharp protrusions to prevent intimal tearing. Only the distal working segment carries long-lasting hydrophilic lubricant, leaving distinct proximal tactile feedback for precise operator control. Balloon diameters range 1.0–4.0mm with lengths 8–20mm, and total shaft length spans 140–160cm; all variants fit standard 0.014” coronary guidewires. Single EO ethylene oxide sterilization applies; reprocessing is fully prohibited, and this device is not indicated for thin-walled intracranial vessel dilation.

Key Highlights

• Dual-Layer Balloon Max 36atm Rated Pressure: powerfully dilating hard, calcified plaques.
• Ultra-Small Crossing Profile 0.0158”: easily navigates through severely calcified stenoses.
• Heat Treated Multi-Fold Balloon: resistant to rupture during repeated inflations.

Technical Specifications & Construction

Typical Clinical Applications

• High-pressure angioplasty for heavily calcified coronary stenosis
• Dilation of rigid fibro-sclerotic lower limb arterial plaques
• Pre-dilation of calcified lesions before drug stent implantation
• Revascularization of partial calcified coronary chronic occlusions
• Severe iliac artery calcified plaque remodeling intervention

Quality Assurance & Compliance

Manufactured in 7,000㎡ Class 10,000 dedicated interventional cleanroom under full ISO13485 quality management framework. Each finished batch undergoes exclusive high-pressure burst fatigue testing, shaft torsion resistance and coating wear cycle verification. Dual-layer balloon polymer raw materials pass full ISO 10993 biocompatibility tests including cytotoxicity, hemolysis and vascular irritation assessment. Complete batch traceability archives are permanently stored to support NMPA Class III medical device, EU CE MDR and US FDA cardiovascular registration globally.

Ordering Information

Our dual-layer ultra-high pressure balloon catheter is supplied to high-volume cardiac catheter labs, peripheral vascular surgery departments and worldwide cardiovascular medical distributors. Long-term bulk cooperation clients receive tiered volume discounts, with custom balloon length specifications and neutral unbranded OEM packaging available for large annual orders. The international sales team provides full compliance documents including ISO13485 certificates, CE MDR technical dossiers, NMPA registration certificates and customs clearance free-sale certificates. Small clinical trial sample orders are accepted for hospital pre-verification; mass production lead time is 16–30 working days after deposit confirmation. One-stop cross-border medical logistics (consolidated shipment, customs declaration guidance) can be arranged on demand. Contact dedicated sales personnel to acquire official product catalog, detailed quotation and minimum order quantity standards.

Frequently Asked Questions (FAQ)